CSV Life Science pure engineering, pure passion
playing perfection in engineering
Engineering is a demanding passion a love for life
CSV Life Science high professional level and great flexibilty in process.
devotion
CSV Life Science serves the pharmaceutical market with engineering solutions and validation services for the Life Science sector, offering significant GxP expertise. Our track record includes leading-edge solutions for the Secondary Pharmaceutical Industry, Medical Device Manufacturers, Laboratories and API Companies, as well as the Fine Chemicals and Food Industries. CSV Life Science has the experience and specialist resources to provide an integrated service covering the entire product life cycle, from the conceptual design and analysis of a department or whole manufacturing site through to basic and detail engineering, qualification, validation and the resolution of any related product release problems in accordance with all the relevant standards. CSV performs in the fields of Validation and Engineering. Over the years, CSV Life Science, has built on the leading expertise of the engineering professionals that founded and drive the company to provide leading-edge Validation, Compliance and Computer System Validation services that are closely tailored to the needs of our customers, both large and small alike. Our know-how in the pharmaceutical and chemical industries brings our clients total peace of mind, knowing that they can rally on a complete solution that addresses every related issue for their company, with a synergistic integration of validation and engineering experience and expertise. It has likewise gained us recognition for delivering the benefits of validation services that are principally orientated to resolving rather than simply identifying any nonconformities encountered. At the same time, we make us an ideal partner for companies seeking the highest standards of professionalism together with outstanding operating flexibility, a combination that can make all the difference to small and medium projects.
FAISIBILTY STUDY&FACILITY PLANNING ENGINEERING DESIGN CONSTRUCTION CONTAINMENT VALIDATION COMPUTER SYSTEM VALIDATION COMPLIANCE GMP SOLUTIONS
Global Knowledge total control Our services meet all needs in a comprehensive and flexible way.
harmony
Engineering In the core of the beginning where everything finds a solid base ENGINEERING DESIGN CSV LIFe SCIenCe offers Conceptual engineering, Basic and Detail engineering services. At the same time our validation background enables CSV LIFe Science to support every project phase taking cGMP problems into account.
foudation
Conceptual engineering Basic engineering Detail engineering
VALIDATION Validation is a requirement, our expertise is a tradition, your confidence is the natural result EQUIPMENT & PLANT VALIDATION Validation is one of traditional sectors in which we have acquired extensive breadth and depth of expertise both in production systems (water for pharmaceutical use and HVAC etc.) and equipment (for solid orals, creams, liquids and sterile products, etc.).
PRECISION
GMP SOLUTIONS The Compliance team offers specialist quality assurance competencies that not only enable them to deliver an “internal quality guarantee service” for our engineering and validation projects, but also to provide our clients with expert support for the typical functions required of their own Quality Assurance and Quality Control organizations and systems. This service is in increasing demand as a result of the relentless pace of today’s technological innovations and constant amendments to the quality and safety requirements of regulatory bodies, which have inevitably led to increasingly rapid changes in the international standards applicable to the pharmaceutical sector. We respond to this need by ensuring that it always keeps pace with the times and is able to provide every client that needs to comply with these changes with a support service that delivers prompt and effective solutions. We offer our clients a full spectrum of services in this area, including: Process, cleaning and methods validation Validation Documentation Review Personnel training QA & QC SOP writing Internal and Supplier Audits GMP reviews Rules and guidelines (US & EU) consultancy Regulatory Issues
SOLUTIONS
COMPLIANCE Today’s technological innovations needs continous solutions, a wide range of possibilities
Compliance area boast of competence in production systems and equipment
Data Sheet Services&Case Histories
CSV LIFE SCIENCE Via Selvanesco 75 20142 MILANO Italia info@csv-ls.com www.csv-ls.com Phone 02 274393.1 Fax 02 274393200